Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV
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Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch : the Nordic-Baltic Bifurcation Study IV. / Kumsars, Indulis; Holm, Niels Ramsing; Niemelä, Matti; Erglis, Andrejs; Kervinen, Kari; Christiansen, Evald Høj; Maeng, Michael; Dombrovskis, Andis; Abraitis, Vytautas; Kibarskis, Aleksandras; Trovik, Thor; Latkovskis, Gustavs; Sondore, Dace; Narbute, Inga; Terkelsen, Christian Juhl; Eskola, Markku; Romppanen, Hannu; Laine, Mika; Jensen, Lisette Okkels; Pietila, Mikko; Gunnes, Pål; Hebsgaard, Lasse; Frobert, Ole; Calais, Fredrik; Hartikainen, Juha; Aarøe, Jens; Ravkilde, Jan; Engstrøm, Thomas; Steigen, Terje K; Thuesen, Leif; Lassen, Jens F; Nordic Baltic bifurcation study group.
In: Open Heart, Vol. 7, No. 1, e000947, 2020.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch
T2 - the Nordic-Baltic Bifurcation Study IV
AU - Kumsars, Indulis
AU - Holm, Niels Ramsing
AU - Niemelä, Matti
AU - Erglis, Andrejs
AU - Kervinen, Kari
AU - Christiansen, Evald Høj
AU - Maeng, Michael
AU - Dombrovskis, Andis
AU - Abraitis, Vytautas
AU - Kibarskis, Aleksandras
AU - Trovik, Thor
AU - Latkovskis, Gustavs
AU - Sondore, Dace
AU - Narbute, Inga
AU - Terkelsen, Christian Juhl
AU - Eskola, Markku
AU - Romppanen, Hannu
AU - Laine, Mika
AU - Jensen, Lisette Okkels
AU - Pietila, Mikko
AU - Gunnes, Pål
AU - Hebsgaard, Lasse
AU - Frobert, Ole
AU - Calais, Fredrik
AU - Hartikainen, Juha
AU - Aarøe, Jens
AU - Ravkilde, Jan
AU - Engstrøm, Thomas
AU - Steigen, Terje K
AU - Thuesen, Leif
AU - Lassen, Jens F
AU - Nordic Baltic bifurcation study group
N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020
Y1 - 2020
N2 - Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.Trial registration number: NCT01496638.
AB - Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.Trial registration number: NCT01496638.
KW - Aged
KW - Angioplasty, Balloon, Coronary/adverse effects
KW - Coronary Artery Disease/diagnostic imaging
KW - Coronary Stenosis/diagnostic imaging
KW - Drug-Eluting Stents
KW - Female
KW - Humans
KW - Latvia
KW - Lithuania
KW - Male
KW - Middle Aged
KW - Myocardial Infarction/etiology
KW - Prospective Studies
KW - Risk Factors
KW - Scandinavian and Nordic Countries
KW - Time Factors
KW - Treatment Outcome
U2 - 10.1136/openhrt-2018-000947
DO - 10.1136/openhrt-2018-000947
M3 - Journal article
C2 - 32076558
VL - 7
JO - Open Heart
JF - Open Heart
SN - 2398-595X
IS - 1
M1 - e000947
ER -
ID: 260771672